The present invention relates to surgical biopsy instruments. Specifically the present invention relates to bone marrow biopsy instruments and to methods of obtaining specimens of bone, marrow and bone marrow fluid with a single puncture. Art pertinent to the present invention is found in U.S. Patent Class 128, Subclass 754, and to corresponding subclasses within Class 604.
Specimens of bone, marrow and the fluids present in the medullary cavity are biopsied to diagnose various diseases such as cancer and leukemia. It is difficult to obtain these specimens, as human bone has a hard outer cortex encapsulating marrow containing medullary cavity.
Traditionally, marrow biopsies have been taken with large bore needles. A first needle with a bore osculating stylet is inserted through an incision in the patient's skin. It is pressed through the muscle tissue and the cortex of the bone, into the medullary cavity. The stylet is withdrawn and a syringe is attached to the needle. Bone marrow fluid is drawn using negative pressure. The first needle is withdrawn. A second needle is then inserted in a second location into contact with the bone's outer surface, the periosteum. The stylet is removed and considerable force is used to penetrate the cortex of the bone. Once the needle is deep enough into the medullary cavity the needle is shifted to an angular position and gyrated to free the marrow sample for withdrawal.
Aspiration and biopsies are most commonly performed on the hip bone (pelvis) in adults and in long bones such as the femur in adolescents.
Biopsy needles are common in the prior art. U.S. Pat. Nos. 2,991,692; 2,426,535; 2,496,111; 4,272,676; 4,266,555; 4,487,209; and 4,840,184 deal with the overall structure and orientation of the components of biopsy needles.
U.S. Pat. No. 4,469,109 speaks to a more or less conventional aspiration needle which employs the use of a depth stop.
Bone marrow biopsy tips are the subject of several U.S. Patents including Islam, U.S. Pat. No. 4,543,966 and Mehl, U.S. Pat. No. 4,922,602.
The ease of use of a bone marrow biopsy needle will greatly effect the level of trauma visited upon the patient. Therefore, handle design has been addressed by many inventors. U.S. Pat. No. 4,630,616 largely deals with the structure of a handle to facilitate use. U.S. Pat. No. 4,838,282 issued to Strasser Jun. 13, 1989 discloses a needle handle mating surfaces to provide proper alignment of the stylet and needle itself. U.S. Pat. No. 3,893,445 is apparently a fairly early bone marrow biopsy needle having a rather unusual handle configuration which appears to be rather difficult to use.
U.S. Pat. No. 4,258,722 issued to Sessions Mar. 31, 1981 discloses a disposable biopsy needle. It employs a stop and a screwdriver type handle. U.S. Pat. No. 4,655,226 issued to Lee, Apr. 7, 1987, discloses a slightly more conventional biopsy needle also described a being disposable.
The current art includes needle designs that can both aspirate and biopsy the marrow, but they still require two 6 separate procedures and punctures.
The three patents most pertinent to the present invention are Turkel, U.S. Pat. No. 2,496,111; U.S. Pat. No. 3,587,560 issued to Glassman Jun. 28, 1971; and Joishy, U.S. Pat. No. 5,012,818 issued May 7, 1991. Turkel '111 is a soft tissue biopsy needle with a coaxial, dual cannula.
Glassman discloses an inner/outer needle structure intended to sample marrow liquid and bone tissue. A needle is first inserted to aspirate a bone marrow liquid sample. A second needle, with saw teeth, is slid over the first needle and a ring section of bone is cut. Glassman doesn't differentiate between solid marrow and marrow liquid.
Joishy discloses a bone marrow needle that takes a sample with a single puncture. It discloses a bulb shaped handle intended to facilitate use. However, the shaft of the needle has side by side semicircular cannulas resulting in a relatively large outside diameter.
Prior art needles have several drawbacks. The core taken by a biopsy needle often comes out of the needle during withdrawal. The prior does not disclose a coaxial needle small enough in diameter to permit one, as a practical matter, to take a bone marrow biopsy with a single puncture. The single puncture instruments present in the prior art inflict significant trauma on patients in an already weakened physical, mental and emotional state.
Hence, it is desirous to provide a needlelike surgical biopsy instrument to obtain both a solid bone marrow biopsy and liquid bone marrow aspirates using a single entry into the bone. This will result in reduced trauma to the patient. Ideally, this instrument would be easy to use and require a minimal of manipulation once inserted. Specifically if the need to gyrate the needle to free the marrow sample were eliminated much of the pain experienced after the initial insertion of the instrument could be eliminated. Another benefit of a single penetration procedure would be a reduction in the time necessary to take the biopsy. Finally, with only a single insertion the risk of infection would be significantly diminished.